复方硫酸锌口服溶液的制备及质量控制

目的:制备复方硫酸锌口服溶液并建立其质量控制方法。方法:以硫酸锌、盐酸赖氨酸为主药制备溶液;分别采用配位滴定法、紫外-可见分光光度法测定其中硫酸锌、盐酸赖氨酸的含量,同时考察制剂稳定性。结果:所制制剂为无色或淡黄色液体,鉴别、检查均符合2005年版《中国药典》中的相关规定。样品中硫酸锌的平均标示含量为101%;盐酸赖氨酸检测浓度的线性范围为3.2～9.6μg·L-1(r=0.9999),平均回收率为99.75%(RSD=0.27%,n=6)。制剂于室温下放置6个月,各项指标未见明显变化。结论:本制剂制备工艺简便可行,质量稳定可控。

Preparation and Quality Control of Compound Zinc Sulfate Oral Solution

OBJECTIVE： To prepare compound zinc sulfate oral solution and establish its quality control method. METHODS： The oral solution was prepared with zinc sulfate and lysine hydrochloride as chief components. The content of lysine hydrochloride was determined by coordination titration and uv spectrophotometry, respectively, and the stability of the preparation was investigated. RESULTS： The oral solution was colorless or yellowish, with its identification and test results all in conformity with the related stipulation stated in Chinese Pharmacopeia （2005 edition）. The average content of zinc sulfate labeled in the sample stood at 101%. The linear range of lysine hydroehloride was 3.2--9.6ug·mL^-1（r = 0.999 9） and its average recovery rate was 99.75% （RSD = 0.27%, n = 6） . The preparation was stable within 6 months storing under room temperature. CONCLUSION： This preparative technology of compound zinc sulfate oral solution is simple and feasible, and the quality of which is stable and controllable.